Whitepapers

Forced degradation studies are critical in biologics development, particularly for monoclonal antibodies (mAbs). These studies simulate long-term environmental stressors to uncover degradation pathways and ensure the stability of critical quality attributes (CQAs), aiding in robust chemistry, manufacturing, and controls (CMC) strategies and regulatory compliance.

3D screen printing provides innovative drug development capabilities that are difficult or impossible to achieve with traditional methods, including complex multi-layered formulations, precision control over drug release profiles, and near-endless possibilities in the geometric shaping of dosage forms. In this article, learn how 3D screen printing offers unmatched flexibility to tailor formulations for specific therapeutic needs and redefines what’s possible in drug development and manufacturing.

Collaborating with a CDMO that has the necessary expertise, equipment, and systems in place is crucial to optimizing the scale-up process and accelerating timelines.

This article explores the challenges found in manufacturing of a pressure vessel as main component for freeze drying technology

ROSS Ribbon Blenders meet the toughest standards for quality and long-term performance. Known worldwide for heavy-duty robust construction, high quality materials and fine craftsmanship, these blenders are available in a variety of customizable configurations ranging from laboratory sizes to 1000 cubic feet. We pay close attention to every detail in design and fabrication, a commitment that translates to higher production value for the end user.

This white paper presents an overview of mixing technologies implemented across many of today’s highly competitive pharmaceutical and medical industries, as well as new equipment designs that are increasingly being recognized as potential solutions to prevailing mixing challenges. Mixing applications falling within the broad spectrum of mass produced pharmaceutical goods and medical devices are too many and complex to discuss in detail hence this paper will touch on a few general classifications as well as a few examples within that mixing category. Phase and viscosity are used as bases for classification.

An inline rotor/stator mixer equipped for powder induction offers flexibility, capability and portability to serve multiple mix vessels of virtually any size. Its straightforward operation and convenience further maximize equipment utility while simplifying material handling.

Consider upgrading your emulsification process to an ultra-high shear mixer to obtain finer droplet sizes and handle higher viscosity emulsions.

Tumble blenders deliver highly accurate and repeatable mixing of powders, granules and even low-viscosity slurries. In addition, this style blender enables complete discharge and easy cleaning. This bulletin presents some design considerations for maximizing mixing efficiency in a tumble blender and selecting the most suitable features for a particular application.

The dream state If we lived in an ideal world, it would be possible to unambiguously identify metabolites using a single analytical experiment. This analytical technique would need to be efficient and easily generate the information needed from a routine assay that is also robust, enabling confident decision-making during drug discovery. At SCIEX, we believe that metabolite identification using the ZenoTOF 7600 system gets close to this dream state.

Read about a material-sparing strategy for developing spray-dried intermediates (SDIs) and their tablet formulations, enhancing bioavailability for poorly soluble active pharmaceutical ingredients (APIs), using erlotinib as a case study. By integrating formulation mapping, polymer screening, and compact screening, the approach enables rapid risk identification and informed decision-making for first-round tablet formulations.

As a leader responsible for metabolite identification in your organization, what keeps you awake at night? SCIEX can give you peace of mind by helping you . . .

Here we discuss a software-assisted drug metabolite identification and characterization workflow. The approach allows scientists to have increased confidence in the process.

Many consumers trust that a Certificate of Analysis (COA) guarantees product safety, but without strict regulatory oversight, that’s not always the case. This white paper provides insights into what consumers and businesses should look for in a truly safe, high-quality, and consistent product.

The regulatory landscape for bioequivalence continues to evolve, leveraging a broader suite of characterization techniques. These not only provide deeper product understanding, but also utility for generic product development as the potential for replacement of costly clinical studies becomes more of a reality.

The identification, characterization, and quantitation of host cell protein (HCP) impurities are a critical challenge in the biopharmaceutical industry. Advanced LC-MS techniques can be integrated into manufacturing workflows to mitigate risks and ensure higher product quality and improved patient safety.

In this case study, Colbert shares the methodology behind its robotic implementation, from defining the scope through vendor selection, design considerations and project wins.

An Overview of RFID Technology for Retail and Healthcare Packaging

Obesity is a significant global health challenge that requires lifestyle changes and effective pharmacological treatments to overcome. Human glucagon-like peptide 1 (GLP-1) analogs, also called incretin mimetics, have emerged as a promising obesity treatment option. Additionally, oral GLP-1 formulations represent a groundbreaking advance in obesity treatment, offering greater patient comfort and adherence to expand the therapeutic market.

This executive summary focuses on dose-flexible manufacturing strategies and their role in drug development. Dose flexibility is increasingly important for early clinical studies, particularly in areas such as pediatric medicines and oncology. However, flexible dosing strategies are often neglected or not prioritized early in development. This presentation will focus on technical strategies that can help anticipate appropriate timing for implementation and how to do so cost effectively while adhering to required timelines.

Carrier-based formulations for dry powder inhalers are carefully designed to transport extremely small particles into the lungs. Jet milling can be used to micronize these particles, with both high and low shear mixing processes used to formulate mixtures capable of carrying the fine API particles into the deep lung. This paper looks at the requirements for pulmonary delivery via carrier-based inhaled powder formulations, and how jet milling can be used to manufacture effective and stable materials for these formulations

Analyzation of a diverse set of PROTAC (Proteolysis Targeting Chimeras – a class of TPDs) structures and their calculated properties, identifying key structure-property trends that contribute to low oral bioavailability.

Meeta B. Kratz (Global Vice President, Product Management & Marketing, Lonza Capsule and Health Ingredients) talks about Lonza's future and how that works in tandem to meet client needs.

A case study in converting a solution formulation of a protein into an oral solid dosage form utilizing a fluid bed granulation process and some of the complexities involved.

The packaging and distribution of clinical supplies is a fundamental piece to the overall success of a clinical trial, and advance preparation can help establish a more efficient supply chain. Selecting the best geographical location for those activities, however, depends on the clinical trial protocol, business decisions, and even the investigational medicinal product (IMP) being studied.

Drive growth by establishing integrated, AI-fueled lab systems and a data-driven corporate culture that’s ready and resilient, no matter what business challenges emerge tomorrow. Evolving to a Lab of the Future takes the right technologies, systems, and expert guidance.